NCT06714825已完成1 期
Phase 1 Single and Multiple Ascending Dose Study in Males and Females Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects
35Pharma Inc1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年11月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Incidence and Number of Adverse Events (AEs)
研究概览
简要总结
Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects
详细描述
A Phase 1 Study Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects: Single Ascending Dose (SAD) in Males and Postmenopausal Females and Multiple Ascending Dose (MAD) in Males and Females of Non-childbearing Potential
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female above 40 years of age, inclusive.
- •Body Mass Index (BMI) between 28 and 40 kg/m2, inclusive.
- •Body weight at or below 140 kg with a stable body weight.
- •In good health or with no clinically significant medical conditions
- •Females who are post-menopausal or are of Non-child bearing Potential.
- •Male subjects must be willing not to donate sperm for 90 days after the last dose.
- •Able to understand the study procedures and provide signed informed consent to participate in the study.
排除标准
- •Females with a positive pregnancy test or who are lactating.
- •Subjects with diabetes or have previous history of diabetes.
- •Subjects who have recently donated blood, plasma and platelets.
- •Subjects with history of alcoholism or drug abuse.
- •Subjects who received systemic or topical medications, depot injections or implants, hormone replacement, non-prescribed medication or herbal remedies, or daily glucocorticoids for > 1 month in previous year.
- •Subjects with clinically significant abnormal pulse or blood pressure or temperature.
- •Subjects with a history of a clinically significant medical disorder or lab abnormality.
- •Subjects with a significant history of multiple drug allergies, including infusion reactions and hypersensitivity to any of the excipients of HS
- •Subjects who are carriers of the hepatitis B surface antigen (HBsAg) and are carriers of the hepatitis C antibody (except if Polymerase Chain Reaction Ribonucleic acid (PCR RNA) is negative); or have a positive result to the test for human immunodeficiency virus (HIV) antigen or antibody.
- •Subjects who have, in the opinion of the Investigator, an abnormality in the echocardiogram or 12-lead ECG that put them at increased risk during the study.
- •Current or history of treatment with medications that may cause significant weight gain or loss, within 3 months or 5 half-lives of screening.
- •Obesity induced by other endocrine disorders.
- •Previous surgical treatment for obesity.
- •Current or history of treatment with medications that may cause significant weight gain or loss.
研究组 & 干预措施
Investigational Product
Experimental
HS235 Subcutaneous Injection
干预措施: HS235 (Biological)
Placebo
Placebo Comparator
Subcutaneous Injection
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and Number of Adverse Events (AEs)
时间窗: up to 106 days for Single dose and 147 days for multiple doses
An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.The incidence and number of patients who experience an AE will be reported.
次要结局
- Area under concentration time curve (AUC) zero to t(up to 106 days for Single dose and 147 days for multiple doses)
- Area under concentration time curve (AUC) zero-infinity(up to 106 days for Single dose and 147 days for multiple doses)
- Maximum observed Plasma Concentration (Cmax)(up to 106 days for Single dose and 147 days for multiple doses)
- Time to maximum concentration (Tmax)(up to 106 days for Single dose and 147 days for multiple doses)
研究者
研究点 (1)
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